Reported Oct 12, 2016 · Terminated
Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product…
Microgenics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Microgenics Corporation · 46500 Kato Rd · Fremont, CA · 94538-7310
Is this the product you have?
- Thermo Scientific QMS Everolimus Assay
- Model number
0380000 (US Distribution)0373852 (Foreign
- Distribution) Product UsageThe QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country
- Lot codes and dates
- Lot number72258049
- Expiry date07/31/2017
- Lot number
72258007Expiry date 07/31/2017
- Amount recalled
- 163 kits in US, 669 kits worldwide - toatal 831.
Where it was sold
Why it was recalled
A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. For controls, maximum bias of +/- 35% for low levels, +/- 33% for mid-range levels, and +/- 47% for high levels is observed. Bias in patient samples ranges from -15.7% to +5.2% with an average bias of -5.6% when comparing the QMS everolimus assay to an everolimus LC-MS reference method. Patient samples across the measuring range sub-therapeutic, therapeutic, and supra-therapeutic could be affected.
This product could cause temporary or reversible health problems — stop using it.
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